Purpose

To evaluate the association of mortality with visual acuity (VA) impairment, age-related macular degeneration (AMD), and cataract surgery.

Design

Cohort study.

Participants

Participants with at least intermediate AMD enrolled in a randomized controlled clinical trial of lutein/zeaxanthin and/or omega-3 fatty acids, the Age-Related Eye Disease Study 2 (AREDS2), for treatment of AMD and cataract.

Methods

Baseline and annual eye examinations included best-corrected visual acuity (BCVA) assessments, slit-lamp examinations, and stereoscopic fundus photographs that were centrally graded for development of late AMD (central geographic atrophy or neovascular AMD) or pseudophakia. Cause-specific mortality was determined on the basis of the International Classification of Diseases 9th or 10th Revision codes. Risk of all-cause and cause-specific mortality was assessed with Cox proportional hazards models adjusted for age, sex, AMD severity, VA, history of cataract surgery, and assigned AREDS2 study treatment. Analyses included baseline covariates: race, education, smoking status, diabetes, and cardiovascular disease.

Results

During follow-up (median 5 years), 368 (9%) of the 4203 AREDS2 participants died. Participants with neovascular AMD in 1 eye at baseline had a statistically significant increased risk for mortality compared with participants with no or few drusen (hazard ratio [HR], 1.56; 95% confidence interval [CI], 1.21–2.01; P < 0.001). Poorer survival was associated with bilateral cataract surgery before enrollment compared with baseline bilateral phakia (HR, 1.63; 95% CI, 1.29–2.07; P < 0.001) and with BCVA of less than 20/40 compared with participants with 20/40 or better (HR, 1.56; 95% CI, 1.06–2.30; P = 0.024), adjusted for age, sex, and statistically significant covariates. Participants who received antivascular endothelial growth factor therapies for neovascular AMD had decreased mortality compared with those who did not (HR, 0.71; 95% CI, 0.57–0.88; P = 0.002). The association between all-cause mortality and AREDS2 treatment whether assessing the main or individual treatment effect was not significantly different (omega-3 fatty acids main effect HR, 1.18; 95% CI, 0.96–1.45; P = 0.12; lutein/zeaxanthin main effect HR, 1.04; 95% CI, 0.85–1.28; P = 0.71).

Conclusions

In AREDS2, the presence of late AMD, bilateral cataract surgery, and VA less than 20/40 was associated with decreased survival. However, oral supplementation with omega-3 fatty acids, lutein plus zeaxanthin, zinc, or beta-carotene had no statistically significant impact on mortality.

中文翻译：

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与年龄有关的眼病研究中，死亡率与眼病和视力障碍的关系2

目的

评估死亡率与视力（VA）损害，年龄相关性黄斑变性（AMD）和白内障手术的关联。

设计

队列研究。

参加者

年龄至少为中级AMD的参与者参加了叶黄素/玉米黄质和/或omega-3脂肪酸的随机对照临床试验，即年龄相关性眼病研究2（AREDS2），用于治疗AMD和白内障。

方法

基线和年度眼科检查包括最佳矫正视敏度（BCVA）评估，裂隙灯检查和立体眼底照片，这些照片针对晚期AMD（中央地理萎缩或新生血管性AMD）或假性晶状体的发展进行了中央分级。基于特定疾病的死亡率是根据《国际疾病分类》第9版或第10版修订版确定的。使用针对年龄，性别，AMD严重程度，VA，白内障手术史调整的Cox比例风险模型评估全因和特定原因死亡的风险，并分配AREDS2研究治疗方法。分析包括基线协变量：种族，教育程度，吸烟状况，糖尿病和心血管疾病。

结果

在随访中（中位5年），有4203名AREDS2参与者中的368人（占9％）死亡。与无或少有玻璃疣的参与者相比，基线时一只眼有新生血管AMD的参与者的死亡风险有统计学上的显着增加（危险比[HR]为1.56； 95％置信区间[CI]为1.21-2.01；P <0.001） 。与基线双侧晶状体晶状体相比，入组前双眼白内障手术的生存较差（HR，1.63； 95％CI，1.29–2.07；P <0.001），且BCVA小于20/40，而参与者为20/40或更高（HR，1.56； 95％CI，1.06–2.30；P = 0.024），针对年龄，性别和统计学上显着的协变量进行了调整。与未接受抗血管内皮生长因子疗法的新生血管AMD相比，参加者的死亡率降低了（HR，0.71； 95％CI，0.57–0.88；P  = 0.002）。无论是评估主要治疗效果还是个体治疗效果，全因死亡率与AREDS2治疗之间的相关性均无显着差异（omega-3脂肪酸的主要作用HR为1.18； 95％CI为0.96-1.45；P  = 0.12；叶黄素/玉米黄质为主要作用HR，1.04； 95％CI，0.85-1.28；P  = 0.71）。

结论

在AREDS2中，晚期AMD，双侧白内障手术和VA小于20/40的存在与生存率降低相关。但是，口服补充omega-3脂肪酸，叶黄素加玉米黄质，锌或β-胡萝卜素对死亡率没有统计学上的显着影响。